BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TNA

    MDR report key: 6057590 · Received October 26, 2016

    Report

    Report Number
    1226420-2016-00163
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 27, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K152703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4): BRIEF DESCRIPTION OF COMPLAINT: THERE WAS A SPARK ARCING FROM THE RIGHT SIDE OF THE WIRE TO THE PATIENT¿S TISSUE. THE WIRE ALSO WAS CLOGGED, BUT VERY FIRM AND THE HOUSING WAS PITTED. NOTHING DETACHED OR FELL INTO THE PATIENT. INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW COMPLAINT DEVICE DETAILS: DEVICE NAME: PLASMABLADE¿ TNA, PRODUCT NUMBER: PS300-002, LOT NUMBER: 0211722320 (NEW DESIGN), EXPIRATION DATE: 03-AUG-2019, QUANTITY RETURNED: 1. TESTING PERFORMED: VISUAL INSPECTION: DEVICE PACKAGING INSPECTION: ONE RETURNED PLASMABLADE¿ TNA DEVICE WAS RECEIVED INSIDE A (B)(6) SHIPPER BOX WITHIN A PLASTIC BAG WITH NO PACKAGING TO FILL THE NEGATIVE SPACE. THE DISPLAY BOX AND THE TYVEK® LID WERE RETURNED; THE DEVICE INFORMATION WAS CONFIRMED AGAINST THE INFORMATION LISTED WITHIN GCH FROM THE DISPLAY BOX AND THE TYVEK® LID. THERE WAS A HANDWRITTEN NOTE ON THE DISPLAY BOX ¿DEMO # 2 ¿ ADENOID - COAG-4 ARC ON THE SIDE, TISSUE BUILDUP, NOTICED WIRE EXPOSURE, GUNKED UP, VERY GUNKY¿. THERE WAS A PRINTED RGA EMAIL PROVIDED. DEVICE VISUAL INSPECTION: THE DEVICE IS USED WITH BLOOD ON THE HANDLE, SHAFT, AND CORD. THERE WERE TWO ATTACHMENT TIPS THAT WERE RETURNED WITH THE DEVICE HANDLE, THE ADENOID TIP, AND THE TONSIL TIP. THE TNA ADENOID TIP ELECTRODE WIRE, PLASTIC HOUSING, AND SUCTION OPENING CONTAIN TISSUE AND COAGULUM BUILDUP, THE PLASTIC HOUSING IS MELTED, HOWEVER, THE ELECTRODE WIRE REMAINS ATTACHED TO THE PLASTIC HOUSING WHICH VISUALLY RELATES TO THE REPORTED COMPLAINT DESCRIPTION; ALL OTHER COMPONENTS APPEAR IN PLACE AND INTACT, FIGURE # 1 THRU FIGURE # 4. ALL ELECTROSURGICAL DEVICES EXHIBIT WEAR DURING USE AND WEAR IS ACCEPTABLE AS LONG AS IT DOES NOT AFFECT THE SAFETY OF THE DEVICE. THE EFFICACY OF THE DEVICE IS NOT AFFECTED BY THE DAMAGE EXHIBITED ON THE DEVICE. THERE ARE EXCESSIVE AMOUNTS OF ESCHAR BUILDUP ON THE RIGHT SIDE OF THE ELECTRODE WIRE, WITH THE MINOR MELTING OF THE PLASTIC HOUSING AT THE LEFT CORNER, AND EXCESSIVE MELTING OF THE PLASTIC HOUSING ON THE RIGHT CORNER, HOWEVER, THE WIRE IS NOT BROKEN. THE DEVICE AND ADENOID TIP WERE CLEANED AND THE ¿TEST METHOD PROCEDURE FOR ADENOID TIP¿ WAS UTILIZED TO DETERMINE IF THE WEAR OF THE WIRE ELECTRODE PLASTIC HOUSING IS ACCEPTABLE, FIGURE # 5 AND FIGURE # 6. ACCEPTABLE DAMAGE: ADENOID TIP THE WIRE REMAINS INTACT. THE WIRE HAS SUPPORT FROM THE PLASTIC HOUSING AND DOES NOT EXHIBIT DEFORMATION IN THE VENTRAL TO DORSAL DIRECTION. ¿ THE MELT-BACK IS NOT WISPY OR STRINGY IN APPEARANCE. UNACCEPTABLE DAMAGE: ADENOID TIP THERE IS, GREATER THAN, > 33% OF THE ¿WIRE SQUARE¿ THAT IS EXPOSED WHICH FAILED TO MEET THE ACCEPTABLE DAMAGE REQUIREMENTS FOR THE WIRE SQUARE EXPOSURE AND RENDERS THE DEVICE NOT SAFE FOR USE. THE TONSIL TIP WAS RETURNED; THE ELECTRODE AND SUCTION OPENING CONTAIN TISSUE AND COAGULUM BUILDUP, HOWEVER, THERE IS NO DAMAGE PRESENT. FIGURE # 7 AND FIGURE # 8. SEE THE REFERENCE PICTURES OF A NEW ADENOID TIP AND A NEW TONSIL TIP FOR COMPARISON, FIGURE # 9 THRU FIGURE # 12. INSUFFICIENT CLEANING, TECHNIQUE, AND USE CONTRIBUTE TO THE TISSUE AND COAGULUM BUILDUP ON THE ELECTRODE WIRE AND PLASTIC HOUSING WHICH CAN DIMINISH DEVICE PERFORMANCE, COMPROMISE THE PLASTIC HOUSING AND CAN CONTRIBUTE TO THE CLOGGING OF THE SUCTION OPENING. THE COMPLAINT COULD NOT BE RECREATED FOR THE DEVICE SPARKING ISSUE THAT WAS REPORTED IN THE COMPLAINT DESCRIPTION; HOWEVER, ACTIVATING THE DEVICE OUTSIDE THE FIELD OF TISSUE CAN CREATE ARCING WHICH CAN CAUSE THE GAP BETWEEN THE TISSUE AND THE DEVICE IN THE FIELD TO CREATE SPARKING. FUNCTIONAL INSPECTION: THE FUNCTIONAL INSPECTION PORTION OF THIS COMPLAINT INSPECTION WAS NOT PERFORMED AS THE COMPLAINT WAS CONFIRMED VIA VISUAL INSPECTION. LHR REVIEW: A REVIEW OF THE LHR FOR LOT # 0211722320 REVEALED THERE WERE NO PROBLEMS DURING MANUFACTURING THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT DESCRIPTION. INVESTIGATION CONCLUSION: COMPLAINT CONFIRMED: THE REPORTED ISSUE CONTAINED WITHIN GCH WAS VISUALLY CONFIRMED FOR THE REPORTED ISSUE OF GUNKING, CLOGGING AND THE WIRE ELECTRODE PLASTIC HOUSING MELTING WITHIN THE LABORATORY ENVIRONMENT. HOWEVER, THE COMPLAINT IS NOT CONFIRMED FOR THE DEVICE SPARKING ISSUE WHICH COULD NOT BE RECREATED. THE ADENOID TIP EXHIBITS UNACCEPTABLE WEAR AS THERE IS GREATER THAN, > 33%, OF THE ¿WIRE SQUARE¿ THAT IS EXPOSED WHICH FAILED TO MEET THE ACCEPTABLE DAMAGE REQUIREMENTS FOR THE WIRE SQUARE EXPOSURE. THIS COMPLAINT WILL BE TRACKED AND TRENDED WITHIN GCH. REFERENCE DOCUMENTS: 42-10-1020 REV. H - WORK INSTRUCTIONS FOR COMPLAINT INVESTIGATIONS - DISPOSABLE DEVICES 31-10-1370 REV. H - PRODUCT SPECIFICATION AND QUALITY PLAN - TNA PRODUCT FAMILY 70-10-1447 REV. C - PEAK PLASMABLADE¿ TNA ¿ IFU 13-90-0014 REV. F ¿ SITUATION ANALYSIS FOR PLASMABLADE¿ ADENOID TIP ELECTRODE DETACHMENT. THE 61-90-0700 REV. D ¿ TEST METHOD PROCEDURE FOR ADENOID TIP TEST EQUIPMENT: THE FUNCTIONAL PORTION OF THIS COMPLAINT INVESTIGATION WAS NOT PERFORMED THEREFORE NO TEST EQUIPMENT WAS UTILIZED DURING THE COMPLAINT INVESTIGATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING AN ENT CASE, THE SURGEON REPORTED A SPARK ARCING FROM THE RIGHT SIDE OF THE PLASMABLADE DEVICE WIRE TO THE PATIENT'S TISSUE. AFTER THE SPARK, THE SURGEON REPORTED THE PLASTIC HOUSING ON THE DEVICE MELTED. THERE WAS NO UNINTENDED TISSUE DAMAGE OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707591 PLASMABLADE TNA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS300-002 0211722320

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR